Topics:

FDA joins public-private group to speed device approval

Tools

The FDA is joining up with the Medical Device Innovation Consortium, a public-private outfit uniting CDRH experts with the likes of Medtronic ($MDT) and Boston Scientific ($BSX), all in the name of advancing regulatory science to speed the path of investigational devices.

The consortium functions as an independent nonprofit, created by Minnesota trade group LifeScience Alley. The group will solicit input from industry, government and other nonprofits and fund projects designed to advance pre-application regulatory sciences, helping companies better design and develop their devices to ensure approval.

For the FDA, the effort promises to make for safer candidate devices in the future. And for industry, the consortium offers a chance to invest upfront and avoid costly delays and re-applications in the future, said Jeffrey Shuren, head of CDRH.

"By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost," Shuren said in a statement.

Last year, the FDA planted the seed for the group in signing a memorandum of understanding with LifeScience Alley to collaborate on regulatory science research. The trade group eventually decided to launch a full-fledged 501c(3) with the same goal, and now the agency is along for the ride. In addition to Medtronic and Boston Sci, they've recruited Abiomed ($ABMD), Becton Dickinson ($BDX) and Cyberonics ($CYBX), among others.

Right now, the consortium is in its early stages, planning first to establish subcommittees that will steer its future efforts. Medtronic R&D Vice President Maura Donovan is serving as interim executive director, and the group hasn't said anything about naming a full-time leader.

- here's the announcement
- check out the consortium's website

Related Articles:
FDA says it's already speeding up device approvals
FDA looks to trim answer times for 510(k) apps
Congressional Dems want FDA to reform 510(k) process